Such labels include a base label portion to be fastened to a container or the like, a supplement portion, e.g., a folder, as well as a top label portion to be fastened to the base label portion and/or to the container or the like, including the supplement portion. The labels are also called laminar or folder labels.
The invention relates specifically, but not exclusively, to labels for the pharmaceutical industry and similar lines of business in which a defective production of labels might have disastrous effects.
Many requirements are attached to the production and the use of laminar labels for the pharmaceutical industry. For instance, the upper side of a laminar label, applied to a container, must appear as a medicament signature according to regulations. Also additional information about the product or instructions for its use must be included here. The signature on the base label must at least adequately agree with the signature on the top label portion, because the product itself must be marked, according to regulations, if the supplement with the top signature and the top label portion is removed. Also, it is important that the serial and shelf-life data information, applied by the pharmaceutical manufacturer, remains on the base label portion and also on the product. This is an important traceability documentation.
Several different printing processes, methods and operations for the application of critical text result in an increased risk-taking. On the majority of laminar labels, the text in the top label signature and the base label signature today is printed in different printing operations and with different printing methods. This results in increased risks of mistakes.
Medicament labels often have 2–4 colors, which are used in order to emphasize critical information. The base label with its signature text is printed separately. The signature text in the top label portion of the laminar label is printed jointly with the information text in the label supplement. In order to make the signature in the top label portion and the base label portion alike the label supplement must have the same number of colors as the base label portion. Owing to this the risks as well as the costs will increase.
One of the most common laminar label solutions is to use a clear, thin and close-fitted, self-adhesive, top label portion in order to enhance the quality as well as to render possible a practical opening and (re)closing. The laminate is often treated on its glue side by the label manufacturer in order to facilitate the opening/closing of the label.
The pharmaceutical industry also prints production data and serial information on the laminar label, which are critical traceability data. On completely laminated laminar labels, these data are printed on the laminate. In case the supplement with the laminate disappears from the container, the remaining basic signature will contain traceability data since they accompany the laminate.
Another element of risk consists of the possibility that the wrong supplement and base label may be brought together. As the majority of laminar labels are produced today, this may involve risks that the base label signature does not correspond to the top label signature and also that the user information is wrong.
There are several known and patented solutions for laminar labels and production processes for them. Most of these solutions consist of three components, produced in three separate processes. This can result in increased risks of faulty production and lower application quality for the finished product, particularly in the following respects: printing variability which results in color variations and the risk of wrong text and wrong assembly of label components. Lower product quality in the form of stiffer labels when paper and glue are used to attach supplements to the base label portion. A glue gets hard and brittle, the label becoming less accommodating. This is particularly important when cylindrical containers are to be labeled.
It is difficult to attach a thick traditional laminar label around a cylinder with a relatively small diameter. When the laminar label has been attached a cylinder, the cylinder diameter of the base label portion will be less than the cylinder diameter of the outer portion of the supplement, the ends of which striving to loose the ends of the base label portion. In order to counteract such an effect, laminar labels have been developed having a base label, a supplement and a top laminate. When cylinders are labeled, the end of the top laminate, which is turned away from the application end, is extended compared to the base label and the supplement. This extension contacts the release paper web and is released from it in the application phase, and the laminate yields to the curvature of the cylinder and is attached without wrinkles on the cylinder surface by means of the glue on the rear face of the laminate.
One example of the state of the art is described in EP 0 833 295 B1, which includes a printed base label portion and a printed brochure with a top signature. The entire label is covered by a laminate and the brochure is attached to the laminate, which fastens the brochure to the container against an extra applied base label portion. The label comprises four portions: a base label, a brochure, a fitted laminate and a separate, specially treated, extra base label portion designed to allow an easy opening/closing of the brochure.
Another example of the state of the art is EP 0 594 560 B1. In this case, the base label is provided with glue, which fastens the lower side of a folder to the base label. The folder and the signature are printed in the same operation. A stiff glue surface means that the label will be stiffer and less flexible. Paper is also stiffer than PP and PE. The self-adhesive base label is designed to support the folder, bind it to a product and make available place for printing of serial and production data. The entire label is covered by a thin, clear laminate in order to enhance the quality and fasten the folder label to the product. The laminate is perforated to allow traceability data on the base label to be visible, in case the folder disappears. A risk of losing the folder exists since perforations, in general, are not completely reliable. It is also necessary to print ink in fields on the glue side of the laminate in order to attain a sufficient gripping power. This label solution reduces the number of text sides with at least one side, since the top face of the label and the last folder side are to be glued to each other.
According to EP 0 506 202 B1, a base label is printed separately and is provided with glue and then a folder is glued to the side of the label. The entire label is then covered by a laminate, which is fastened to a product. The production and its advantages and drawbacks roughly correspond to those described in the preceding example.